(55 days)
No
The provided text describes a synthetic bone void filler and does not mention any AI or ML components or functionalities.
No.
The device is a bone void filler that helps to fill bone defects and resorbs as new bone forms; it does not treat or cure a disease or condition.
No
The device is described as a bone void filler and graft substitute, which is a therapeutic function, not a diagnostic one. Its purpose is to fill bone defects and facilitate bone formation, not to identify or assess a medical condition.
No
The device description explicitly states it is a "synthetic resorbable calcium phosphate bone void filler" and describes its physical properties (porosity, pore size, shapes, and sizes), indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that OsteoPore TCP is for "filling bone voids or defects of the skeletal system". This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a "synthetic resorbable calcium phosphate bone void filler" that acts as an "osteoconductive material". This describes a material used within the body to aid in bone healing, not a test performed on samples outside the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. OsteoPore TCP does not fit this description.
N/A
Intended Use / Indications for Use
OSTEOPORE TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OSTEOPORE TCP should be gently packed into the defect/void without under filling or over filling. OSTEOPORE TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
The OSTEOPORE TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (such as the extremities, spine and the pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
VII. 510(k) Summarv
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
SpineCraft, Inc. 2215 Enterprise Drive Suite 1504 Westchester, IL 60154 Telephone: 708-531-9700 Date Prepared: August 21, 2006.
B. Device Name
Trade or Proprietary Name: OsteoPore TCP Common or Usual Name: Bone Void Filler Classification Name: Unclassified
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared device Kasios TCP (K042340).
D. Device Description
The OSTEOPORE TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
E. Intended Use
OSTEOPORE TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OSTEOPORE TCP should be gently packed into the defect/void without under filling or over filling. OSTEOPORE TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
F. Substantial Equivalence
Data was provided which demonstrated the OSTEOPORE TCP to be substantially equivalent to the previously cleared device. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
SpineCraft, Incorporated c/o Ms. Ami Akallal-Asaad Regulatory Affairs Manager 2215 Enterprise Drive, Suite 1504 Westchester, Illinois 60154
Re: K062496
Trade/Device Name: Osteopore TCP Regulation Number: 21 CFR §888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: October 6, 2006 Received: October 10, 2006
Dear Ms. Akallal-Asaad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Akallal-Asaad
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Kula Palang
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. Indications for Use
510(k) Number (if known): K062496
Device Name: OsteoPore TCP
Indications for Use:
OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoPore TCP should be gently packed into the defect/void without under-filling or over-filling. OsteoPore TCP is a Jonne graft substitute that resorbs and is replaced with bone during the healing process.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_